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Human medicine European public assessment report (EPAR): Tezspire (new)
tezepelumab, Asthma
Date of authorisation: 19/09/2022,
, Authorised, Last updated: 21/09/2022
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Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Accord
metformin hydrochloride, sitagliptin hydrochloride monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 22/07/2022,
, Revision: 1, Authorised, Last updated: 01/09/2022
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Human medicine European public assessment report (EPAR): Zokinvy
Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022,, 
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, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Lupkynis (updated)
Voclosporin, Lupus Nephritis
Date of authorisation: 15/09/2022,, Authorised, Last updated: 20/09/2022
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Human medicine European public assessment report (EPAR): Opdualag (updated)
nivolumab, Relatlimab, Melanoma
Date of authorisation: 15/09/2022,, Authorised, Last updated: 20/09/2022
Nerve Tissue Neoplasms Cancer Nevi and Melanomas Melanoma … melanoma (a type of skin cancer) that has spread or cannot … from 12 years of age whose cancer cells produce a low level … -
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Human medicine European public assessment report (EPAR): Nulibry (updated)
fosdenopterin hydrobromide dihydrate, Metal Metabolism, Inborn Errors
Date of authorisation: 15/09/2022,, , Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Illuzyce (updated)
lutetium (177Lu) chloride, Radionuclide Imaging
Date of authorisation: 15/09/2022, Authorised, Last updated: 21/09/2022neuroendocrine tumors and prostate cancer, used together with imaging … carry a risk of developing cancer and hereditary defects. The … neuroendocrine tumors and prostate cancer, used together with imaging … -
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva (updated)
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,, Revision: 3, Authorised, Last updated: 06/10/2022
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Human medicine European public assessment report (EPAR): Sunlenca
Lenacapavir sodium, HIV Infections
Date of authorisation: 17/08/2022,, Authorised, Last updated: 25/08/2022
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Human medicine European public assessment report (EPAR): Pepaxti
Melphalan flufenamide hydrochloride, Multiple Myeloma
Date of authorisation: 17/08/2022, Authorised, Last updated: 06/09/2022with multiple myeloma (a cancer of the bone marrow) when the cancer has not responded to previous … transplantation to when the cancer comes back is at least three … this medicine, is a type of cancer medicine known as an alkylating … -
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Human medicine European public assessment report (EPAR): Zolsketil pegylated liposomal
doxorubicin hydrochloride, liposomal, Ovarian Neoplasms; Sarcoma, Kaposi; Multiple Myeloma
Date of authorisation: 31/05/2022, Authorised, Last updated: 20/06/2022treat the following types of cancer in adults: • breast cancer that has spread to other … disease; • advanced ovarian cancer in women whose previous treatment … including a platinum-based cancer medicine has stopped working … -
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Human medicine European public assessment report (EPAR): Vyvgart (updated)
Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022,, , Revision: 1, Authorised, Last updated: 28/09/2022
System Nervous System Neoplasms Cancer Neoplasms Paraneoplastic … -
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Human medicine European public assessment report (EPAR): Vegzelma (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 17/08/2022,, 
, Revision: 1, Authorised, Last updated: 26/09/2022
Neoplasms Digestive System Neoplasms Cancer Neoplasms Breast Diseases Skin … bevacizumab Overview Vegzelma is a cancer medicine used to treat adults … with the following types of cancer, in combination with other cancer medicines cancer of the colon (large intestine … -
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Human medicine European public assessment report (EPAR): Scemblix
asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022,, , Authorised, Last updated: 07/09/2022
Conditions, Signs and Symptoms Cancer Neoplasms Leukemia, Myelogenous … asciminib Overview Scemblix is a cancer medicine. It is used to treat … myeloid leukaemia (CML), a cancer of the white blood cells … -
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Human medicine European public assessment report (EPAR): Roctavian (updated)
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,, , 
, Authorised, Last updated: 28/09/2022
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Human medicine European public assessment report (EPAR): Camcevi
leuprorelin mesilate, Prostatic Neoplasms
Date of authorisation: 24/05/2022, Authorised, Last updated: 20/06/2022Diseases Male Urogenital Diseases Cancer Neoplasms Prostatic Neoplas … treatment of advanced prostate cancer that is ‘hormone-dependent’ … hormone-dependent prostate cancer and high-risk localised prostate … -
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Human medicine European public assessment report (EPAR): Sondelbay
teriparatide, Osteoporosis
Date of authorisation: 24/03/2022,, , Authorised, Last updated: 16/06/2022
as Paget’s disease, bone cancer or bone metastases cancer that has spread to the bone … Paget’s disease, bone cancer or bone metastases cancer that has spread to the bone … -
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Human medicine European public assessment report (EPAR): Xenpozyme
Olipudase alfa, Acid sphingomyelinase deficiency (ASMD) type A/B or type B
Date of authorisation: 24/06/2022,, , Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Upstaza (updated)
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,, , , Revision: 2, Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Sugammadex Fresenius Kabi
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 15/07/2022,, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Padcev
Enfortumab vedotin, Carcinoma, Transitional Cell; Urologic Neoplasms
Date of authorisation: 13/04/2022,, Authorised, Last updated: 18/05/2022
Padcev Cancer Neoplasms, Glandular and … Padcev is a cancer medicine for treating adults … treating adults with urothelial cancer (a cancer of the bladder and urinary … -
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Human medicine European public assessment report (EPAR): Tepmetko
Tepotinib hydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2022,, Authorised, Last updated: 05/05/2022
Neoplasms Thoracic Neoplasms Neoplasms Cancer Respiratory Tract Diseases Lung … Tepmetko is a cancer medicine that is used to … with non-small cell lung cancer (NSCLC) when the cancer is advanced and its cells … -
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Human medicine European public assessment report (EPAR): Quviviq (updated)
daridorexant hydrochloride, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/04/2022,, Revision: 2, Authorised, Last updated: 13/09/2022
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Human medicine European public assessment report (EPAR): Kimmtrak
tebentafusp, Uveal Neoplasms
Date of authorisation: 01/04/2022,, , Authorised, Last updated: 22/04/2022
adults with a type of eye cancer called ‘uveal melanoma’ … experienced in the use of cancer medicines and the treatment … surface of uveal melanoma cancer cells and CD3 on the surface … -
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Human medicine European public assessment report (EPAR): Tabrecta (updated)
capmatinib dihydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/06/2022,, Authorised, Last updated: 21/09/2022
Neoplasms Thoracic Neoplasms Cancer Neoplasms Lung Diseases Respiratory … adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the cancer is advanced and its cells … adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the cancer is advanced and its cells …